Revance Therapeutics to Initiate Two Key Trials for RT001, Its Topical Botulinum Toxin Type A Investigational Drug Product Candidate

Revance Therapeutics, Inc.

, a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced its plans to move forward with two key clinical studies for its investigational drug product candidate RT001, a topical gel formulation of botulinum toxin type A. "We recently conducted an open-label study for the treatment of crow's feet lines, which enrolled an aggregate of 69 subjects across multiple sites. In the study, we evaluated the 28-day efficacy of a single topical application of the RT001 drug products tested. The subject response observed in the open-label study, taken together with our analysis of prior studies and early data from newly developed clinical methods, has led us to proceed with our RT001 U.S. Phase 3 clinical trial for the treatment of crow's feet lines. Based upon what we have learned, we believe we have an opportunity to achieve clinical and statistical significance in a Phase 3 clinical study," said Dan Browne, President and Chief Executive Officer at Revance. "We are making promising advances in the development of clinical methods, such as electromyography (EMG), intended to demonstrate the ability of RT001 to effectively cross the skin and achieve an associated paralytic effect directly on the target muscle," continued Browne. In the second half of 2015, Revance plans to initiate a U.S. Phase 3 pivotal study to evaluate the safety and efficacy of a single topical application of RT001 on adults with moderate to severe crow's feet lines. The company also plans to begin a U.S. Phase 2 study to evaluate the safety and efficacy of a single application of topical RT001 on adults with moderate to severe axillary hyperhidrosis, or excessive sweating. Revance plans to provide trial design details and timelines for these studies when each commences later this year. "We are pleased to be moving ahead with the development of RT001, which has the potential to transform today's botulinum toxin market. By eliminating the need for needles in aesthetic and therapeutic treatments, we believe our topical RT001 could significantly expand the estimated $3 billion neurotoxin market by removing many of the barriers that currently keep patients from adopting its use, including pain and bruising," concluded Browne. RT001 and RT002 Drug Product Candidates Revance is currently developing two botulinum toxin type A investigational drug product candidates. RT001 is a topical formulation, which has the potential to be the first commercially available non-injectable dose form of botulinum toxin type A. Revance is studying topical RT001 for aesthetic indications, such as crow's feet lines (wrinkles around the eyes) and therapeutic indications such as hyperhidrosis (excessive sweating). RT002 is a novel, injectable formulation of botulinum toxin type A designed to be more targeted and longer lasting than currently available injectable botulinum toxin products. Revance is studying injectable RT002 for aesthetic indications, such as glabellar (frown) lines and therapeutic uses, such as muscle movement disorders (cervical dystonia and upper limb spasticity). Both products would have the potential to expand into additional aesthetic and therapeutic indications in the future.